What does compliance of a product with USP-NF standards entail?
A. An article of commerce that is recognized in the USP-NF complies with the USP-NF standards when the article meets all of the requirements stated in the article’s monograph, applicable General Chapters, and the General Notices (with monograph requirements superseding those of the General Chapters and General Notices, in any cases where requirements differ). Applicable standards apply at all times in the life of an article, from production to expiration. Thus, any official article is expected to meet the compendial standards if tested, and any official article actually tested as directed in the relevant monograph must meet such standards to demonstrate compliance. Frequency of testing and sampling are left to the preferences or direction of those performing compliance testing, including manufacturers, buyers, or regulatory authorities. back to top Q.
